Minimal invasive electrophysiology procedures to treat cardiac arrhythmias are increasing growing in popularity, due to technological advancements in penetrative technologies, which provide enhanced control on the clinical procedures. However, current standard electrophysiology guidance methods, utilize mostly fluoroscopy for locating the catheter position and movement. Long subjection of the patents and practitioners to fluoroscopic exposure are potentially hazardous. Noninvasive ultrasonic imaging is currently one of the effective noninvasive techniques for human diagnosis of the internal lumens. The most popular ultrasound imaging is currently provided by the pulse-echo modality, in which the piezoelectric transducers act as both acoustic sources and detectors of the ultrasound waves. Current scanner transducers, existing as 1D, or 1.5D, elongated phase arrays, consist of one, or a few rows of piezoelectric transducer elements and require mechanical manipulation for volumetric imaging. The second dimension of the transducer allows additional electronic elevation scanning and focusing and the use of phase aberration correction algorithms to reduce the B-scan slice thickness, thus achieving better spatial resolution. Consequently, true 2D ultrasonic transducer phase-arrays are necessary for the following: improving the focusing depth and spatial resolution, achieving high speed volumetric scanning without mechanical movement and obtaining angle independence flow imaging without significant aberrations. Based on its patented laser ultraprecision micromachining technique of straight and curved delineation in exotic materials, as well as its expertise in aerospace interconnection, and in electronics supporting high-density array of active elements, LEEOAT Company offers an opportunity to develop in high-quality piezoelectric material, a high-density, high-performance two-dimensional (2D) ultrasound phase-array transducer (2D-UPAT) with high-aspect-ratio pixels. The 2D-UPAT will be integrated into a forward looking intracardiac imaging catheter to support guidance and diagnosis during electrophysiology procedures. Teaming with Duke University, the pioneering institute in ultrasound volumetric imaging, and utilizing our wide expertise in micromachining and aerospace high-density microconnections and packaging, we will develop a small size 2D-UPAT prototype and imaging system to be integrated into forward looking intracardiac imaging catheters for electrophysiology procedures. Recently, LEEOAT Company has reduced the innovation to practice by successfully demonstrating high-frequency (7.8 MHz) ultrasound imaging of a miniature 2D-UPAT prototype, which was tested in collaboration with Duke University, using special calibrated medical phantoms. In phase I of the NIH SBIR program, LEEOAT Company will develop, simulate, fabricate and test a high-performance and cost-effective high-density two-dimensional phase-array ultrasonic transducer (2D-UPAT) to comprise the forward looking intracardiac imager, with the goal of an 360 hard-wired multiplexed element array of =100x100 [unreadable]m2 pixels and broad-band operation at around 7 MHz central frequency. The transducer array will be hybridized and wired into a narrow prototype, all contained in a 4 mm flexible tube. In phase II of the SBIR program, the miniature 2D-UPAT will be integrated to comprise the forward looking intracardiac imaging catheter, to support real-time guidance and diagnosis during electrophysiology procedures. For final testing, the miniature 2D-UPAT module will be connected to the T5 transmit/receive electronics and the corresponding data processor hardware and software at Duke University. Additionally, the innovative high-efficiency 2D-UPAT module prototypes will support various small size and robust penetrative volumetric ultrasound imaging systems, for high-resolution, real-time medical imaging diagnostic applications (endoscopic ultrasound, laparoscopic surgery, robotic surgery etc.). PUBLIC HEALTH RELEVANCE: In phase I of the SBIR program, LEEOAT Company will develop, simulate, fabricate and test a high performance two dimensional ultrasound phase array transducer for forward looking penetrative echocardiographic imaging. Based on its patented micromachining technique in exotic materials, as well as its expertise in aerospace interconnections and electronics supporting high-density array of active elements, LEEOAT Company offers the opportunity to develop in a high-quality piezoelectric material a high-density high performance two dimensional ultrasound phase array transducer. The miniature transducer will be integrated into a forward looking intracardiac imaging catheter to assist real-time guidance during interventional electrophysiology procedures.